MEDICAL DEVICE SECTOR CAPABILITIES SUMMARY

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HARBEC Inc. 369 Route 104

Ontario, NY 14519-8999 www.harbec.com

(585) 265-0010 1(888) 521-4416 toll free

(585) 265-1306 Fax info@harbec.com

Achieving Differentiated Results

At HARBEC, we understand that, in order to remain competitive in the health

care market, you must keep up with rapidly changing technological and

scientific advances.

Parts (e.g., switches and implanted micro-devices) are becoming miniaturized.

Stationary products are now portable. Buyers are increasingly more cost-

conscious. And the industry at large is being driven to meet ever increasing

demands related to quality, reliability, shorter development cycles and product

lifecycles.

HARBEC will work with you to produce best-in-class components to be

integrated into your products: laboratory apparatus, surgical instruments,

therapeutic devices and dental equipment. We can produce components for

imaging equipment, patient monitors, pacemakers, joint replacements, plastic

instruments for the ear, nose and throat industry and more — we will work

with to you to provide higher levels of reliability and performance and get your

product to market quickly and efficiently.

You can trust HARBEC to do it right.

MEDICAL DEVICE SECTOR CAPABILITIES SUMMARY

MEDICAL DEVICE SECTOR CAPABILITIES SUMMARY

Are you a company that is:

In need of scientific molding and statistical analysis to meet stringent requirements?

Concerned about the quality and reliability of sensitive medical equipment manufacturing?

Considering alternative materials to ensure

your medical instrument can withstand heat and moisture?

Developing a miniature medical device to

increase user comfort and decrease visibility?

Modifying your project for improved manufacturability?

In need of tight tolerances and microdeburring under magnification?

Seeking to reduce the weight of your

portable equipment?

We Are Precision.

For more than 40 years HARBEC, Inc. has been a

leader in precision parts manufacturing for the

medical device sector.

Medical device manufacturing has very strict

requirements for production cleanliness,

product quality, packaging, and labeling.

HARBEC maintains stringent quality standards

and practices so that it continuously earns the

trust of some of the most discerning medical

device customers.

From surgical robotics to spinal implants,

HARBEC’s precision manufactured components

are called upon for the most critical healthcare

applications and environments.

MANUFACTURING SOLUTIONS

MEDICAL DEVICE SECTOR CAPABILITIES SUMMARY

Reliability, Risk, Responsibility, and Reward

The medical device sector has very discerning requirements. Precision engineering and manufacturing solutions are essential for competitive differentiation and success.

The strength of your R&D efforts is your competitive differentiation. The ability to solve new diagnostic and treatment challenges is critical.

HARBEC has manufactured precision parts for customers in the medical device sector, meeting the most stringent customer requirements and demanding applications.

With that comes adherence to very tight part tolerances, superior performance, speed, agility, efficiency, and for many, 100% inspection.

Quality and Performance

The HARBEC Quality Team has the experience, capabilities, equipment

and software to meet the demanding quality requirements of our

diverse customer base. Working within the ISO 9001 framework we

are dedicated to excellence throughout the design, prototype and

production life cycle of a part. We emphasize designing parts, tooling

and processes for optimal quality control, in production through

rigorous inspection and SPC practices. HARBEC routinely performs

internal audits of our “closed loop” quality management and

documentation system, always striving for continual improvement. We

take pride in delivering high-quality parts to our customers. At

HARBEC we don’t confine quality to a department – quality is a

company-wide commitment. We are also working towards ISO

13485 which will be achieved in 2016.

Certifications

ITAR

ISO 9001:2008

ISO 14001:2004

ISO 50001 SEP

MEDICAL DEVICE SECTOR CAPABILITIES SUMMARY

Advanced Manufacturing

HARBEC has made and continues to make, significant

investments to earn the right to be a preferred medical

device manufacturer for some of the world’s leading

medical device companies. HARBEC’s investment in

state-of-the-art CNC milling machines, production

capable 3D printing, and clean room molding have

provided medical device customers with the speed,

accuracy, quality, and tolerance they need to produce

high-value medical products.

Whether it is a 3D model, a precision cut mold out of

aluminum or steel, intricate titanium parts milled at

incredibly tight tolerances, or mid-to-high volume

injection molded parts from a cleanroom environment,

HARBEC has a solution for your need.

Sample Components

For the medical device sector HARBEC

manufactures components such as:

• spinal implants

• MRI and imaging components

• surgical robots

• dialysis and IV components

• medication disbursement devices

• reagent closures

• surgical head lamps

• blood and DNA collection and

analysis devices

HARBEC has clean room molding, and

also works with a range of challenging

materials for molding and machining